Senior Scientist, Process Development-Cell Based Assay

BPS Bioscience•San Diego, CA

4d•$110,000 - $120,000

About The Position

BPS Bioscience Inc. is seeking an exceptional senior scientist with a strong background in cell biology, mammalian cell culture, signal transduction, reporter gene systems, and functional cell-based assay technologies. The ideal candidate will have excellent experience in the validation of engineered cell lines, including gene overexpression, knock-in, and knockout models, as well as hands-on expertise in the validation and characterization of lentiviral and AAV-based products. Strong flow cytometry proficiency is required. The Senior Scientist, Process Development-Cell Based Assay, will lead the design, optimization, and scale-up of robust manufacturing and QC processes for BPS Bioscience’s cell-based product lines. This is a hands-on, lab bench role where the candidate will actively perform laboratory experiments, validate and transfer new cell-based products and processes, and establish product specifications. The position requires direct expertise in cell line engineering, process characterization, technology transfer, and continuous improvement. The candidate must be highly skilled in cell-based assay development, mammalian cell culture, transfection, cell line engineering, and functional assay qualification. The ideal candidate will work with minimal guidance, execute experiments to a very high standard, troubleshoot technical and scientific problems, and effectively progress multiple projects simultaneously.

Requirements

Ph.D. in Cell Biology, Molecular Biology, Biochemistry, Immunology, Bioengineering, or related discipline.
8+ years of relevant experience in cell-based assay development and process development, preferably in the biotech, pharmaceutical, or life science research reagents industry, with direct hands-on experience in stable cell line engineering, functional cell-based assay manufacturing, and recombinant cell line production.
Demonstrated expertise in mammalian cell culture and primary cells, stable cell line generation (lentiviral transduction, CRISPR/Cas9 knock-in and knockout, gene overexpression, selection/cloning), and cell banking (MCB/WCB qualification).
Proven experience validating engineered cell lines including overexpression, knock-in, and knockout models through molecular, phenotypic, and functional characterization.
Demonstrated hands-on experience with a broad range of cell-based assay technologies including luciferase/bioluminescence reporter assays and excellent flow cytometry expertise are required, including multicolor panel design, data analysis, and cell sorting for QC and research applications; experience with lentivirus and AAV product validation (titer, transduction efficiency, functional potency) is required; direct experience with BPS Bioscience product types (e.g., nuclear receptor reporter cell lines, immune checkpoint reporter lines, GPCR/CRE assays, CAR-T/NK functional tools) strongly preferred.
Experience with process characterization, scale-up, and technology transfer of cell-based products from development to commercial manufacturing; strong understanding of ISO 9001:2015, GLP, and regulatory requirements relevant to cell-based research reagent manufacturing and QC.
Demonstrated ability to work independently and manage multiple projects, with a track record of delivering results in a fast-paced, multitasking environment.
Excellent analytical, troubleshooting, and problem-solving skills, including strong understanding of assay performance metrics and statistical methods for method validation.
Strong teamwork, organizational, and communication skills; proven ability to collaborate across R&D, manufacturing, and quality functions; detail-oriented and committed to data integrity and quality.
Hands-on experience with statistical analysis and DoE using JMP, Spotfire, or GraphPad Prism in manufacturing and QC; skilled in trending process and QC data, establishing/refining product specifications, and supporting stability and shelf-life studies for cell-based products.

Responsibilities

Lead the design, validation, and optimization of manufacturing and QC processes for BPS Bioscience’s cell-based products, including stable luciferase reporter cell lines (HEK293, Jurkat, Raw264.7, CHO, and others), transient transfection assay kits, immune checkpoint reporter cell lines, CAR-T/NK cell functional assay tools, and GPCR/ion channel assay systems.
Characterize, and validate stable cell lines using lentiviral transduction, plasmid transfection, CRISPR/Cas9 gene editing, and selection-based cloning strategies; confirm identity, stability, and functional performance through molecular and phenotypic characterization.
Qualify, and validate cell-based assay methods including luciferase reporter assays, HTRF, FRET, BRET, cAMP, calcium flux, cytokine release, cytotoxicity (ADCC, CDC), proliferation, and flow cytometry-based assays in compliance with GLP and ISO 9001:2015 standards.
Validate and transfer new cell-based products and processes from R&D to manufacturing and quality control, ensuring seamless technology transfer, process robustness, and implementation across production scales.
Establish product specifications, release criteria, and QC methods for cell-based products; set and refine acceptance criteria for critical quality attributes including cell viability, passage number limits, mycoplasma testing, stability testing, functional potency, and signal-to-background ratios.
Manage mammalian cell banking activities including master/working cell bank preparation, cryopreservation, and qualification; ensure cell stocks meet identity, viability, and sterility requirements for commercial manufacturing.
Drive process optimization initiatives using DoE and statistical process control to enhance cell line productivity, assay reproducibility, shelf-life, and scalability; troubleshoot deviations, perform root cause analysis, and implement corrective and preventive actions (CAPAs).
Collaborate cross-functionally with R&D, manufacturing, and quality teams, and serve as a scientific interface with external partners and customers for technical discussions related to cell-based products.
Author technical validation protocols, SOPs, batch records, validation reports, and review technical data sheets for cell-based products; mentor and train junior scientists to ensure high bench depth and technical competency in cell-based assay techniques.
Participate in regular department and cross-functional meetings and present scientific data; monitor competitive landscape and emerging technologies to identify opportunities to enhance BPS Bioscience’s cell-based product offerings and processes.